Paragraph 10 Amendment of Schedule 8 (Adjustment, reduction or refund of periodic fees)I1

Schedule 8 is amended as follows.

In the heading, after “Adjustment”, insert “ , waiver ”.

After paragraph 2, insert—

“Waiver or refund: converted EU marketing authorisations

2A

(1)

Where the licensing authority revokes a converted EU marketing authorisation in accordance with paragraph 6(3) of Schedule 33A to the Human Medicines Regulations, the periodic fee payable under regulation 38(1) in relation to that authorisation shall be refunded, or if it has not yet been paid, shall be waived.

(2)

In this paragraph, “converted EU marketing authorisation” has the meaning given in paragraph 6(1) and (2) of Schedule 33A to the 2012 Regulations.”